Events

Recall of Device Recall BCI Advisor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical PM, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38128
  • Event Risk Class
    Class 2
  • Event Number
    Z-1089-2007
  • Event Initiated Date
    2007-06-05
  • Event Date Posted
    2007-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53006
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Vital Signs Monitor - Product Code MWI
  • Reason
    Turn off unexpectedly/ not turn on : monitors turned off unexpectedly sounding the critical failure alarm. advisor vital signs monitors that were off, would not turn back on.
  • Action
    Consignees will be contacted via a Safety Action Bulletin 07-SAB02 dated June 5, 2007. Technical Worksheet, 07-TW01 including a kit will be sent to the International consignees whom Technical Service has deemed qualified to perform the repair. The repair will be performed at the consignee site. International consignees who require or request the repair be done at the Smiths Medical PM, Inc. Technical Service department will return their monitors for repair.

Device

Device Recall BCI Advisor
  • Model / Serial
    Serial Number AM07030098 AM07030097 AM07030100 AM07030099 AM07030018 AM07020155 AM07020154 AM07020152 AM07020153 AM07030010 AM07030005 AM07030013 AM07030014 AM07030015 AM07030012 AM07030006 AM07030008 AM07030011 AM07030016 AM07030017 AM07030004 AM07030009 AM07030007 AM07030000 AM07030001 AM07030101 AM07030103 AM07030019 AM07020159 AM07020164 AM07020163 AM07020161 AM07020165 AM07020166 AM07020157 AM07020162 AM07020158 AM07020160 AM07020049 AM07020047 AM07020039 AM07020048 AM07020050 AM07020064 AM07030002 AM07030003 AM07030148 AM07030114 AM07020179 AM07020168 AM07020167 AM07030112 AM07020173 AM07020172 AM07020126 AM07030109 AM07020169
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel
  • Product Description
    BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • Manufacturer Address
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA